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Exercise Intolerance in Obstructive Sleep Apnea Syndrome Patients (EXAOS)

This study has been completed.
Sponsor:
Collaborator:
AGIR à Dom
Information provided by (Responsible Party):
University Hospital, Grenoble
ClinicalTrials.gov Identifier:
NCT00837018
First received: February 3, 2009
Last updated: March 4, 2013
Last verified: March 2013

February 3, 2009
March 4, 2013
June 2005
May 2010   (final data collection date for primary outcome measure)
Comparison of maximal oxygen consumption : OSAS patient versus control subjects. [ Time Frame: when the last patient realised the last visit ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00837018 on ClinicalTrials.gov Archive Site
To compare physical exercise program to continuous positive airway pressure after 12 weeks of treatment in OSAS patients. [ Time Frame: when the last patient realised the last visit ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Exercise Intolerance in Obstructive Sleep Apnea Syndrome Patients
Exercise Intolerance in Obstructive Sleep Apnea Syndrome Patients: Cardiovascular and Metabolic Characterisation During Exercise. Treatments Effect.

The syndrome of obstructive sleep apnea (OSAS) is a public health problem that affects 2 to 4% of the general population. The patients with OSAS frequently complain of intolerance to exercise muscle fatigue and a significant even if they have not been fully characterized in the literature.

The anomalies in the exercise of patients with OSAS could be due to metabolic changes (insulin resistance and oxidative stress) and cardiovascular (impaired vascular reactivity).

Our goal is both to determine whether these anomalies exist in patients with OSAS not obese, consider their relationship with the alteration of exercise capacity, and their reversibility in conventional PPC or by using the effects of physical activity regular.In this study Objectives: To establish whether the metabolic and vascular abnormalities associated with OSAS are associated with decreased parameters of physical fitness in relation to witnesses matched for age, sex and body mass index. Determine the effects of a re-training exercise on these parameters compared to the reference treatment, continuous positive pressure.

Main objective: To compare the exercise capacity of OSAS patients compared with that of witnesses matched for age, sex and body mass index.

Secondary objectives: To compare the effect of conventional treatment by continuous positive pressure (CPP) on cardiovascular and metabolic abnormalities of OSAS, with a therapeutic modality most original, physical activity.

Methodology: Test physiopathological parallel group, controlled, randomized.

Study type : Physiopathology trial Study design : Prospective randomized controled trial

Expected Total Enrollment : 45 patients + 15 control subjects

Tested treatment : Physical exercise program (45 minutes, 3 times a week) Reference treatment : continuous positive airway pressure Treatment duration : 12 weeks (3 months) Total study duration : 2 years

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Subject)
Obstructive Sleep Apnea
Other: physical exercise program
45 min, 3times a week
Experimental: Physical exercise program
45 min, 3 times a week
Intervention: Other: physical exercise program
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
May 2012
May 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Ages Eligible for Study : 18 Years and above
  • Genders Eligible for Study: Both
  • Non obese : body mass index (BMI < 30 kg/m2)
  • Sedentary subjects : less physical activity than 30 minutes 3 time a week
  • and VOORIPS physical activity level questionnaire score < 9.

Obstructive sleep apnea syndrome (OSAS) patients :

  • Recently diagnosed (< 3 months)
  • AHI > 30 / hour (polysomnographic monitoring measurement)

Exclusion Criteria:

  • Excessive daytime sleepiness (Epworth score > 12)
  • Cardiovascular pathology (except controlled hypertension)
  • Pathology interacting with physical activity
  • Diabetes (known or treated)
  • Other participation to a clinical trial at the same
Both
40 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00837018
0520, DGS 2005/0312
No
University Hospital, Grenoble
University Hospital, Grenoble
AGIR à Dom
Principal Investigator: Bernard Wuyam, doctor CHU Grenoble
University Hospital, Grenoble
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP